K241217
- 510(k) number
- K241217
- Device name
- CloudHRV System (100-01-001)
- Applicant
- Inmedix, Inc. WA · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2025-01-16
- Date received
- 2024-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241217.pdf
Official FDA record: K241217
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.